Evaluation of pelvic organ prolapse using upright magnetic resonance imaging

Completed

Conditions: Pelvic floor dysfunction - Prolapse
10046828
10029903

Registration Number: NL-OMON45910

Lead Sponsor: niversiteit Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

For patients:
Signed informed consent
Symptomatic grade 2 pelvic organ prolapse
Planned for surgery (anterior and/or posterior wall repair, Manchester, sacrocolpopexie);For volunteers without pelvic floor disorders:
Signed informed consent
In same age and BMI category as the patient population
At least one vaginal delivery

Exclusion Criteria

Previous prolapse surgery
Hip waist >47 cm
Not eligible for MRI, in response to the MRI safety checklist
Inability to stand for 15 minutes, without assistance;Additionally for healthy volunteers:
No prior history of pelvic organ complaints

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The aim of this explorative study is to evaluate existing clinical parameters<br /><br>that are developed for supine MRI (angles, distances, function/composition of<br /><br>the muscle) in upright scanning and to assess how these parameters change<br /><br>between supine and upright MRI scanning in both volunteers without pelvic floor<br /><br>disorders and patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate if there is a correlation between the anatomical severity of POP,<br /><br>as measured with POP-Q, and the parameters obtained with MRI.<br /><br>To evaluate if there is a correlation between the parameters obtained from the<br /><br>MR images pre- and post- operative.<br /><br>*To explore if additional parameters can be defined, based on the upright MRI<br /><br>scan, that may be of interest to the surgeon and outcome of surgical treatment,<br /><br>which can be further tested for their clinical merit in a future trial</p><br>